In the period from 2018 to 2023, 28 percent of clinical drug trials started during these years were in the field of oncology, whereas a combined 13 percent of trials started were for infectious diseases (therapeutic and immunization). This statistic depicts the proportion of clinical trials started worldwide from 2018 to 2023, by key therapeutic area.

The probability that a cancer drug will make it from phase I to final approval stood at some *** percent, according to a study published in March 2020. The data is based on clinical success rate models from 2014, 2016, and 2019. Once a cancer drug made it into phase III, the chances to make it to final approval increased to **** percent.

This statistic shows the number of clinical trial participants in the U.S. compared to the rest of the world in 2015-2019, by therapeutic area. In the oncology and hematology area, there were some 9,200 clinical trial participants in the United States whereas there were 25,700 participants in the rest of the world.

Decentralized trials, real-world evidence, and adaptive study designs are reshaping the clinical trial landscape. Pharma and biotech companies are increasingly outsourcing to CROs for speed, compliance, and access to diverse patient pools.

In 2023, 41 percent of clinical drug trials for oncology were in phase II and 14 percent of trials were in phase III. This statistic shows the share of clinical drug trials in the top five therapeutic areas worldwide in 2023, by trial phase.

The global Clinical Trials Site Management Organizations (CTSMOs) market is experiencing robust growth, driven by the increasing complexity of clinical trials, the rising demand for specialized expertise in site selection and management, and the growing adoption of decentralized clinical trials (DCTs). The market size in 2025 is estimated at $5 billion, exhibiting a Compound Annual Growth Rate (CAGR) of 12% during the forecast period 2025-2033. This significant growth is fueled by several key factors including the increasing prevalence of chronic diseases necessitating extensive clinical trials, the rising adoption of advanced technologies like AI and big data analytics in clinical research, and a growing preference for outsourcing site management to specialized organizations. The market is segmented by trial phase (Phase I-IV) and therapeutic area (Respiratory Diseases, Pain & Anesthesia, Oncology, Central Nervous System, Cardiovascular, Endocrine, Anti-Infective, Others), offering CTSMOs opportunities to specialize and cater to specific client needs. Geographical expansion, particularly in emerging markets like Asia-Pacific and Latin America, presents further growth potential. Despite these opportunities, the market faces some challenges. These include regulatory hurdles and compliance complexities associated with running clinical trials across diverse geographical locations. Additionally, price competition and the need for consistent quality control across multiple sites can pose obstacles. However, strategic partnerships, investments in technology, and a focus on providing superior service quality will enable leading CTSMOs to navigate these challenges and capture substantial market share. The growing trend towards patient-centric clinical trial designs is expected to further propel the demand for efficient and specialized site management services, creating a sustained growth trajectory for the market throughout the forecast period. The expansion of clinical trials into diverse therapeutic areas further fuels this expansion, increasing the need for specialized CTSMOs.

The AI in Clinical Trials Market Report is Segmented by Component Type (Software and Services), Therapeutic Area (Oncology, and More), Clinical Trial Phase (Phase I, and More), Deployment Model (Cloud, and More), End User (Pharmaceutical and Biotech Companies, and More), and Geography (North America, Europe, Asia-Pacific, The Middle East and Africa, and South America). The Market Forecasts are Provided in Terms of Value (USD).

Language requirements in clinical trials by therapeutic area.

The global clinical trial material (CTM) market is experiencing robust growth, driven by the increasing number of clinical trials across diverse therapeutic areas and a rising demand for advanced therapies. The market, estimated at $15 billion in 2025, is projected to exhibit a Compound Annual Growth Rate (CAGR) of 7% between 2025 and 2033, reaching approximately $25 billion by 2033. Key drivers include the escalating prevalence of chronic diseases like cardiovascular diseases, cancer, and neurological disorders, leading to a surge in clinical trials worldwide. Furthermore, the growing adoption of innovative drug modalities, such as biologics and advanced therapies, is fueling demand for specialized CTM handling and storage solutions. Significant growth is observed in the oncology and CNS segments, reflecting the high investment in research and development for these therapeutic areas. The market is segmented by application (Oncology, CNS, Cardiovascular Diseases, Digestive Disorders, Immunology, Blood Disorders, Other) and type (Small-molecules, Biologic Drugs, Medical Devices). The increasing outsourcing of CTM management to specialized contract research organizations (CROs) further contributes to market expansion. Geographical analysis reveals strong market presence in North America and Europe, driven by well-established healthcare infrastructure and regulatory frameworks. However, Asia-Pacific is anticipated to witness substantial growth due to increasing investments in healthcare infrastructure, growing pharmaceutical industry, and rising prevalence of chronic diseases in developing economies like India and China. While factors like stringent regulatory requirements and high costs associated with CTM management pose certain restraints, the overall market outlook remains positive due to consistent growth in the pharmaceutical and biotechnology industries and ongoing innovation in drug development. The competitive landscape is characterized by a mix of large multinational CROs and specialized CTM providers, suggesting a highly dynamic market with potential for both consolidation and new entrants.

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US Clinical Trials Market Size 2025-2029

The us clinical trials market size is valued to increase USD 6.5 billion, at a CAGR of 5.3% from 2024 to 2029. Rise in number of clinical trials of drugs will drive the us clinical trials market.

Major Market Trends & Insights

By Type - Phase III segment was valued at USD 9.50 billion in 2022
By Service Type - Interventional studies segment accounted for the largest market revenue share in 2022

Market Size & Forecast

Market Opportunities: USD 61.02 billion
Market Future Opportunities: USD 6.50 billion
CAGR from 2024 to 2029 : 5.3%

Market Summary

The Clinical Trials Market in the US is a dynamic and evolving landscape shaped by advancements in core technologies and applications, service types, and regulatory frameworks. With the rise in the number of clinical trials for drugs, the market is witnessing significant growth. According to a recent report, the adoption rate of electronic data capture (EDC) systems in clinical trials has surged to over 70%, revolutionizing data management and analysis. However, the increasing cost of clinical trials poses a major challenge for market participants. In 2020, the average cost of a Phase III trial was estimated to be around USD4.5 billion. Despite these challenges, opportunities abound, particularly in areas such as personalized medicine and remote patient monitoring. As technology and scientific research continue to advance, the Clinical Trials Market in the US remains an exciting and innovative space.

What will be the Size of the US Clinical Trials Market during the forecast period?

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How is the Clinical Trials in US Market Segmented and what are the key trends of market segmentation?

The clinical trials in us industry research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in 'USD billion' for the period 2025-2029, as well as historical data from 2019-2023 for the following segments. TypePhase IIIPhase IPhase IIPhase IVService TypeInterventional studiesObservational studiesExpanded access studiesIndicationOncologyCNSAutoimmune/inflammationOthersGeographyNorth AmericaUS

By Type Insights

The phase iii segment is estimated to witness significant growth during the forecast period.

The clinical trials market in the US is a dynamic and evolving landscape, with ongoing activities and emerging patterns shaping the drug development process. Phase 3 trials, a crucial segment, assess the safety and efficacy of new drugs or treatments on larger patient populations. In April 2024, the FDA granted accelerated approval to Enhertu for adult patients with unresectable or metastatic HER2-positive solid tumors who have previously undergone systemic treatment. This approval underscores Enhertu's potential to address a significant unmet need, solidifying its role in the market. Throughout the clinical trial process, from protocol development and sample size calculation to patient recruitment, informed consent, and adverse event reporting, regulatory compliance is paramount. Technological advancements, such as electronic health records, remote patient monitoring, and eCRF systems, facilitate more efficient data collection and management. Study design, including blinded, placebo-controlled, and parallel group trials, ensures rigorous testing and unbiased results. Adaptive clinical trials allow for real-time data analysis and adjustments, enhancing trial efficiency. Key aspects, like clinical data management, biomarker identification, and statistical analysis plans, ensure data integrity and standardization. Investigator training, interim analysis, and trial monitoring maintain study quality and regulatory compliance. With a focus on data privacy and security, the clinical trials market continues to evolve, addressing the needs of patients and stakeholders alike.

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The Phase III segment was valued at USD 9.50 billion in 2019 and showed a gradual increase during the forecast period.

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Market Dynamics

Our researchers analyzed the data with 2024 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.

The clinical trials market in the US is witnessing significant advancements, driven by the adoption of innovative technologies and strategies to streamline trial processes and enhance patient engagement. One such technology, the clinical trial data management system, is gaining traction due to its ability to facilitate efficient data collection, processing, and reporting. This system integrates various tools such as remote patient monitoring technology, electronic case report forms (eCRFs), and clinical trial data visualization too

Global Clinical Trial Investigative Site Network Market size was valued at USD 6.41 Billion in 2024 and is projected to reach USD 14.24 Billion by 2032 growing at a CAGR of 10.5% during the forecast period 2026-2032.A substantial rise in pharmaceutical research and development initiatives is being witnessed globally. New therapeutic compounds are being developed at an accelerated pace, with investigative site networks being utilized to support the growing pipeline of clinical trials across various therapeutic areas.A significant increase in chronic disease burden is being observed worldwide, particularly in aging populations. Clinical trial investigative site networks are being expanded to accommodate the growing demand for innovative treatments targeting cancer, diabetes, and cardiovascular disorders.

Patient Recruitment For Clinical Trials Market size was valued at USD 980 Million in 2024 and is projected to reach USD 1828.78 Million by 2032, growing at a CAGR of 8.11% during the forecast period 2026 to 2032.Growing Number of Clinical Trials: Increasing drug development efforts across various therapeutic areas require more participants, pushing sponsors and CROs to prioritize efficient and targeted patient recruitment strategies.Rising Prevalence of Chronic Diseases: Chronic conditions such as cancer, diabetes, and cardiovascular diseases create continuous demand for new treatments, increasing the need for large-scale patient enrollment in clinical research.Digital and Social Media Outreach: Sponsors use digital tools and social platforms to identify, reach, and engage potential trial participants quickly, improving recruitment speed and accuracy across demographics.

Drug development is costly and uncertain, with success rates varying widely across therapeutic areas and phases. Predicting the Probability of Trial Success (PTS) can guide better R&D investment, pipeline prioritization, and business development decisions. The challenge is to develop a machine learning model that predicts the PTS for ongoing (active) Phase-3 clinical trials, based on learnings from historical trials.

Data Provided

1. Historical Trials Dataset (Training Set):
   • 1273 completed trial IDs (https://clinicaltrials.gov/) with known outcomes (Failed/Approved)
2. Active Trials Dataset (Test Set):
   • 340 active trials (Trial IDs only)

The Decentralized and Digitalized Clinical Trials market is experiencing robust growth, projected to reach $17.69 billion in 2025 and exhibiting a Compound Annual Growth Rate (CAGR) of 11.1% from 2025 to 2033. This expansion is fueled by several key factors. Increasing adoption of digital technologies throughout the healthcare sector streamlines trial processes, reducing costs and accelerating timelines. The rising prevalence of chronic diseases necessitates faster and more efficient clinical research methods, creating a strong demand for decentralized and digital solutions. Furthermore, patient-centric approaches, including remote data collection and participation options, are gaining traction, improving recruitment and retention rates. This shift allows broader geographic reach, particularly advantageous in accessing underserved populations. The market segmentation reveals strong growth across web-based and cloud-based platforms, with oncology and cardiovascular applications leading the way, reflecting the high prevalence and research intensity in these therapeutic areas. The diverse range of companies involved, including established players like Medidata and IQVIA alongside emerging innovative firms, indicates a competitive but dynamic landscape ripe for further innovation. The geographic distribution showcases significant contributions from North America, driven by advanced technological infrastructure and high healthcare spending. However, the Asia Pacific region presents a considerable growth opportunity, given its expanding healthcare industry and increasing investment in clinical research infrastructure. While challenges remain—such as regulatory hurdles, data security concerns, and the need for robust technological infrastructure in certain regions—the overall market outlook remains exceptionally positive. The continuous evolution of technology, coupled with the inherent advantages of decentralized trials, points towards sustained expansion throughout the forecast period, with opportunities for further market penetration and innovation in therapeutic areas beyond oncology and cardiology.

The Pediatric Clinical Trials Market Report is Segmented by Phase (Phase I, Phase II, Phase III, and Phase IV), Study Design (Interventional - Drug, Interventional - Device and More), Therapeutic Area (Respiratory Diseases, Infectious Diseases, Oncology, Diabetes and More), Sponsor Type (Pharma & Biopharma Companies and More), and Geography (North America, Europe and More). The Market Forecasts are Provided in Terms of Value (USD).

Healthcare Contract Research Outsourcing Market size was valued at USD 43.22 Billion in 2024 and is projected to reach USD 75.66 Billion by 2032, growing at a CAGR of 7.25% during the forecast period 2026-2032.Increasing R&D Complexity and Cost Pressures: The pharmaceutical and biotechnology industries face escalating complexity in drug discovery and development, coupled with mounting research and development (R&D) expenditure. Bringing a new drug to market requires extensive preclinical testing, rigorous clinical trials, and intricate regulatory submissions, each demanding specialized expertise and significant financial investment. This escalating cost burden, alongside the inherent risk of failure in R&D, compels many organizations to seek external solutions. CROs offer access to specialized talent, advanced technologies, and established infrastructure, allowing pharmaceutical companies to de-risk their R&D pipelines, optimize resource allocation, and accelerate timelines. By outsourcing non-core research activities, companies can focus their internal resources on strategic decision-making and core competencies, ultimately improving their return on investment and enhancing their competitive edge in a demanding market. This strategic outsourcing also enables smaller biotech firms with limited resources to access capabilities typically found in larger organizations, fostering innovation and the advancement of novel therapies.